Ali McBride, PharmD, MS, BCPS: Preparing for Biosimilar Rituximab

Transcript

I think with biosimilar rituximab, we’re still waiting to see what the indication is. I think that's going to be a lot more of a pause. We know there’s a lot of discussion of the number of indications that these new therapies will have, especially in the broad range, for example, there may be patent protection issues. There will be a lot of discussion on what can be done for these therapies in the non-Hodgkin lymphoma setting and also maybe [acute lymphoblastic leukemia, ALL] settings as well based on the indication of the treatment. So, I think we’re all a little concerned about what’s going to happen with rituximab, the biosimilar coming out, what we’re calling the actual “skinny label” if you've ever heard that, sorry for the quotes everybody, but the skinny label is actually going to be a smaller FDA indication list that the biosimilar rituximab may actually have come out.

At this point I'm not aware of what's happening with FDA and also the current rituximab approval, but the key point is going to be what is FDA-approved based on this discussion, and also will payers—it's going to be a very unique if not pivotal discussion—will payers allow for off-label indications of the biosimilar as compared to the original product?

So what that means is you may only have 2 or 3 indications with rituximab, but the package insert with the approval on there for the original product carries 10. If those 8 are off-label, will payers allow for extrapolation to an off-label biosimilar product? [This is] very different from what we had before with the rituximab off-label discussion, which is actually you know, drugs are not approved an indication or Rituxan not being approved in the indication, but again studies being out there for efficacy. We're actually leading into a very unique direction of patent discussions, patent settlements, and also patent infringements, and how we're not there for some of those patent cliffs for this drug therapy.

We're really looking for some guidance in this area with payers. I think payers need to actually voice some of this discussion early on so we can kind of guide ourselves [on] what to do, because if we don't, we may need to actually have a brand-name drug therapy out there and also a biosimilar drug out there on the same shelf because payers may have different understandings of what that off label discussion will be from implementation of biosimilar rituximab.

So we're looking forward to it, but I think there needs to be a lot more discussion, upfront discussion, with payers at this point in time, because it may make a huge difference on our practice sites depending on how much rituximab they use.